Coalition warns patients there are no safe substitutes for authentic,
FDA approved injectables

NEW YORK, Oct. 8 /PRNewswire-USNewswire/ -- Cheaper, unbranded,
unapproved and counterfeit cosmetic injectables are a threat to your looks
and your health warns the Physicians Coalition for Injectable Safety. "The
growing acceptance of cosmetic injections for their good outcomes and
convenience in treatment comes with consumer cautions," says Coalition
leader, plastic surgeon Jeffrey Kenkel, MD of Dallas, Texas. "Disreputable
injectors and counterfeit, imported or unapproved injectables present the
greatest risk to a patient's appearance, and ultimately one's health." In
the period between 2004 and July 2008 the U.S. Food and Drug
Administration's (FDA) Office of Criminal Investigations (OCI) entered in
210 investigations that led to 68 arrests and 29 convictions of health care
professionals who purposely injected an unapproved, cheaper substitute
toxin for FDA-approved Botox(R) Cosmetic into nearly 1,000 unknowing
patients. Specifically what is injected and by whom are important details
no consumer should take casually.

"Cosmetic injections can be highly gratifying procedures. The
Coalition, which represents doctors dedicated to treating cosmetic and
aging concerns of the face, encourages consumers who seek a positive
experience to ask questions of one's injector regarding their experience
and about the product being injected. It might be best to shy away if there
are any incomplete or unclear answers," says Coalition leader, oculoplastic
surgeon Roger Dailey, MD, FACS of Portland, Oregon. "Anyone, including
consumers, who suspect the criminal act of soliciting non-approved,
off-shore, counterfeit or illicit injectables in the U.S. is urged to
anonymously report the suspected illegal activity to the FDA." Information
on reporting a suspected crime to the FDA can be found at
http://www.fda.gov/consumer/updates/oci072307.html.

The Coalition, charged with educating consumers on safe choices in
cosmetic injections and eradicating the use of counterfeit and illegally
imported cosmetic injectables suggests all consumers follow very cautious
steps for both safe, and positive outcomes:

-- Doctor: Ask specifically about your doctor or injector's

qualifications. Choose a doctor who specializes in treating all cosmetic

concerns of the face, such as a board certified plastic surgeon, facial

plastic surgeon, oculoplastic surgeon or dermatologist and who examines

you, prescribes and performs cosmetic injections in a licensed and

properly equipped medical facility. Establish a positive and on-going

relationship with your doctor and follow-up as directed. A nurse or

physician's assistant may perform your injection if you elect, but

a licensed physician must prescribe the treatment.

-- Brand: Ask specifically the brand name of the injectable recommended for

you, the approval status of regulatory agencies in the country where you

will be treated (the U.S. FDA in the United States) and about any

potential outcomes and the likelihood of adverse events. If your doctor

does not offer, ask specifically to see the packaging and identifying

marks that can verify authenticity, including the serial and lot number

(which as a matter of proper procedure must be recorded in your medical

chart). For reference, images of all U.S. FDA approved brand logos and

The Physicians Coalition for Injectable Safety is an alliance of
specialty physician organizations including the American Society for
Aesthetic Plastic Surgery, American Academy of Facial Plastic and
Reconstructive Surgery, the American Society of Ophthalmic Plastic and
Reconstructive Surgery, the International Society for Aesthetic Plastic
Surgery and the Canadian Society for Aesthetic Plastic Surgery. The mission
of the Coalition is to provide the public with unbiased and necessary
information on injectable cosmetic treatments, appropriate injectors and
where to safely access cosmetic medical procedures. Our goal is to promote
treatment supervised by properly qualified and trained, board-certified
doctors and to promote only the use of U.S. FDA-approved, appropriately
administered product. More information can be found at
http://www.injectablesafety.org.

About ASAPS

The 2400-member American Society for Aesthetic Plastic Surgery (ASAPS),
founded in 1967, is the leading professional organization of plastic
surgeons certified by the American Board of Plastic Surgery who specialize
in cosmetic plastic surgery. With 2,100 members in the U.S., Canada, and
many other countries, ASAPS is at the forefront of innovation in aesthetic
plastic surgery around the world.

About AAFPRS

The American Academy of Facial Plastic and Reconstructive Surgery is
the world's largest specialty association that represents over 2,700 facial
plastic and reconstructive surgeons throughout the world. The AAFPRS is a
National Medical Specialty Society of the American Medical Association
(AMA), and holds an official seat in both the AMA House of Delegates and
the American College of Surgeons board of governors. AAFPRS members are
board certified surgeons whose focus is surgery of the face, head, and
neck.

About ASOPRS

The American Society of Ophthalmic Plastic and Reconstructive Surgery
represent surgeons qualified in plastic surgery of the eyelids and
surrounding facial structures. Fellows of the Society are board certified
in ophthalmology, have completed fellowships in ocular surgery (currently
two years), and perform aesthetic, plastic, and reconstructive surgery of
the face, orbits, eyelids, and lacrimal system.

About ISAPS

Founded in 1970 at the United Nations in New York, ISAPS represents
1650 members in 85 countries and is the leading authority in international
aesthetic plastic surgery. Members must pass stringent admission criteria
and are all board certified or the equivalent in their home country. More
information can be found at http://www.isaps.org.

About CSAPS

The Canadian Society for Aesthetic Plastic Surgery is the only
professional organization in Canada dedicated to improved cosmetic surgery
outcomes through education, research, and the maintenance of high surgical
standards of clinical practice. Our membership is comprised of fully
trained and certified specialists in plastic surgery who have demonstrated
their commitment to excellence in the cosmetic and aesthetic areas of our
specialty.

About IFFPSS

The International Federation of Facial Plastic Surgery Societies
(IFFPSS) is a group of societies of facial plastic surgeons from various
countries around the world. This Federation was formed in 1997. The goals
of the IFFPSS are to promote and support the growth of Facial Plastic
Surgery throughout the world. Education, in every form, is the primary
focus of this support.

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